Dendracin Neurodendraxcin Lotion
FDA Label NDC 80425-0458

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Dendracin Neurodendraxcin (NDC 80425-0458). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses:, keep away from children and pets., warnings:, directions:, do not use:, stop use and ask a physician:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Keep Away From Children And Pets.

If swallowed get medical help or contact a Poison Control Center right away.

Warnings:

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

Directions:

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If placed into eyes, rinse with cold water and call a doctor.

Do Not Use:

On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C.

Stop Use And Ask A Physician:

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Benzocaine, Borago Officinalis Seed Oil (Borage Oil), Cetyl Alcohol, Dimethyl Sulfoxide, DMDM Hydantoin, Glyceryl Stearate, Methylparaben, PEG 100 Stearate, Poloxamer 407, Propylene Glycol, Propylparaben, Lecithin (Soy), Stearic Acid, Sodium Stearoyl Glucamate, Triethanolamine, Water, Officinale Root Extract.

Other

Manufactured for Physician’s Science and Nature Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Distributed by:

Advanced Rx of Tennessee, LLC

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